FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
SA-3000P
K Number: K073323
·
Decision Nov 29, 2007
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
52
Applicant Total
3
Review Days
2
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Basic Information
- Device Name
- SA-3000P
- K Number
- K073323
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2780
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medicore Co., Ltd.
- Date Received
- November 27, 2007
- Decision Date
- November 29, 2007
- Product Code
- JOM
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | FDA class 2 | Cardiovascular |
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